The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Bipolar Lead Adaptor, Model Ba-415.
| Device ID | K790218 |
| 510k Number | K790218 |
| Device Name: | BIPOLAR LEAD ADAPTOR, MODEL BA-415 |
| Classification | Pacemaker Lead Adaptor |
| Applicant | PACESETTER SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-30 |
| Decision Date | 1979-08-10 |